A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain

A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain

This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.

Inclusion Criteria:

• Children with clinical diagnosis of PWS；
• Age range: 7 to 14 years-old；
• Voluntarily participated and Written informed consent signed

Exclusion Criteria:

• Therapy area located outside of head and neck;
• Other skin diseases that might interfere with the efficacy evaluation;
• Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
• Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
• Scar diathesis;
• Immunocompromised conditions;
• Electrocardiographic abnormalities or organic heart diseases;
• Coagulation disorders;
• Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN);
• Psychiatric diseases; Severe endocrinopathies;
• Previous therapy of PWS within the last 4 weeks;
• Participation in any clinical studies within the last 4 weeks;
• Be judged not suitable to participate the study by the investigators